Sen. Richard Durbin, D-Ill.
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“It is my strong belief that, if you do not take decisive action within the next ten days, you should resign your post. If you continue to refuse to do your job — which is to protect the public health — then it is time to allow someone else to take the helm,” Durbin wrote in a letter to Sharpless on Friday.
Durbin asked the FDA to send a letter to all schools warning of health consequences of vaping, ban all e-cigarette flavors other than tobacco and to ban e-cigarette devices that the FDA has not cleared and remove them from stores. The FDA has allowed the relatively young e-cigarette market to flourish without any kind of product reviews.
“I have expressed these concerns to you on multiple occasions — in person, on phone calls, and in letters — as well as to your predecessor, Dr. Scott Gottlieb,” Durbin wrote. “And yet, FDA has refused to act in any type of meaningful way.”
The FDA, under former Commissioner Gottlieb, pushed back the deadline to start reviewing e-cigarettes to 2022 from 2018. A U.S. District Court earlier this summer ordered the FDA to start taking applications in 10 months, siding with public health groups who sued the agency for allegedly shirking its legal duties.
Durbin has long criticized the FDA, saying the agency allowed what regulators are calling an “epidemic” of teen vaping. The FDA is under even more pressure amid an outbreak of a mysterious lung disease that is thought to be linked to vaping and has sickened possibly hundreds and killed at least three people.
Durbin asked Sharpless and Mitch Zeller, director of the FDA’s Center for Tobacco Products, to schedule a time to brief senators next week on the steps the agency is taking to address vaping-related illnesses and deaths.